Probiotic supplementation to support gut health, immune response, and well-being in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, single-center study enrolling 50 adults aged 18–65 with mild to moderate perceived stress. Participants will be assigned to probiotic capsules or matching placebo for 56 days, with a 1-week run-in period and visits at screening, pre-intervention, and post-intervention. Biological samples (blood and stool) will be analyzed for gut barrier markers, intestinal inflammation, microbiome composition, short-chain fatty acids, and immune function, alongside questionnaires on stress, quality of life, mood, and digestive symptoms. Safety monitoring will include adverse events and vital signs throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Volunteer is healthy at the time of screening according to participant's own statements.
* TICS SSCS score ≥ 6.
* Male or female aged ≥18 and ≤65 years at the time of screening.
* BMI ≥18.5 and ≤29.9 kg/m².
* Volunteer is able and willing to comply with the study instructions.
* Volunteer is suitable for participation in the study according to the investigator/study personnel.
* Voluntary, written informed consent to participate in the study.

Exclusion Criteria:

* No command of local language.
* Currently diagnosed neurological or psychiatric disorders.
* Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.
* Contraindication or allergy to any ingredient in the verum or Placebo product.
* Use of drugs in the previous 4 weeks before the beginning of intervention.
* Use of laxatives and labelled pre#and probiotics in the previous 2 weeks before the beginning of intervention.
* Participation in another study with any investigational product within 30 days of screening, or less than five elimination half-lives after the last administration of the investigational product (whichever period is longer) or during the study.
* History of drug (recreational) or alcohol abuse.
* Bowel preparation for investigative procedures in the 4 weeks prior to screening.
* Surgical resection of any part of the bowel (excl. appendectomy).
* Pregnant or lactating female, or pregnancy planned during study period, or women of childbearing potential who are not using a medically approved form of contraception (at least three months prior to screening).
* Regular smoking.

Where it's running

• daacro GmbH & Co.KG
  Trier, Germany Recruiting

Study contacts

• Study coordinator: Juliane Hellhammer, PhD
• Email: hellhammer@daacro.de
• Phone: +49 651 9120 494

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.